US9055932B2 - Suture fastener combination device - Google Patents

Abstract

A closure system for closing openings in tissue that includes a closure device and a fastener. The closure device includes shafts that are configured to deploy a fastener to close an opening in tissue. The closure device can deploy the fastener as a knot pusher to close the opening with sutures or as a knot replacement to close the opening with sutures.

Description

BACKGROUND OF THE INVENTION

1. The Field of the Invention

Embodiments of the invention relate generally to medical devices. More particularly, embodiments of the invention relate to systems and methods for closing openings in tissue.

2. The Relevant Technology

Catheterization and interventional procedures, such as angioplasty or stenting, are generally performed through a patient's vascular system. These procedures often begin by inserting a hollow needle through the patient's skin and tissue into the vascular system. A guide wire may be advanced through the needle and into the patient's blood vessel accessed by the needle. The needle is then removed, enabling an introducer sheath to be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to a dilator.

A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guide wire into a position for performing a medical procedure. Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath are removed, leaving a puncture site or opening in the vessel wall. Traditionally, external pressure would be applied to the puncture site until clotting and wound sealing occur; however, the patient must remain bedridden for a substantial period after clotting to ensure closure of the opening. This procedure may be time consuming and expensive, requiring as much as an hour of a physician's or nurse's time. It is also uncomfortable for the patient and requires that the patient remain immobilized in the operating room, catheter lab, or holding area. In addition, a risk of hematoma exists from bleeding before hemostasis occurs.

Therefore, a need exists to close holes in tissue. There is also a need to provide physicians and nurses with options for closing holes or other openings in tissue.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the invention relate to systems and methods for closing opening in tissue. Embodiments of the invention can close openings in tissue by operating as a knot pushing system or as a knot replacement system. A fastener included can either push a knot formed in sutures to close the opening or act as a knot replacement such that tying the knot is not required.

In one example, a closure system for closing an opening in tissue is provided. The closure system includes a fastener. The fastener includes an opening formed therein and sutures are received or drawn through the opening. The closure system also includes a closure device configured to deploy the fastener. The closure device includes an outer shaft and an actuator shaft that are configured to deploy the fastener as either a knot replacement or a knot pusher. The closure device is also configured to trim the sutures after deployment. The closure device may include cutters formed or included in the outer and actuator shafts that are configured to trim the sutures by relative movement of the outer and actuator shafts.

In another embodiment, a closure device for closing an opening in tissue is provided. The closure device includes an actuator shaft and an outer shaft. The actuator shaft is configured to move slidably within the outer shaft. Each of the outer shaft and the actuator shaft has an opening formed therein with a cutter. Relative movement of the outer and actuator shafts causes the cutters to trim the sutures. The outer shaft includes a recess that is configured to removably receive a fastener. Distal movement of the actuator shaft relative to the outer shaft dislodges the fastener from the recess.

In another embodiment, a method for closing an opening in tissue is provided. The method includes loading a closure device with a fastener. When loading the closure device, sutures are drawn through the fastener and through an opening a sidewall of the closure device. Then, the fastener is deployed from the closure device and the sutures are trimmed at the opening in the sidewall of the closure device.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify at least some of the advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated embodiments of the invention and are therefore not to be considered limiting of its scope. Embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1 shows an illustrative embodiment of a fastener that can be implemented as a knot pusher or a knot replacement device and used in closing an opening in tissue;

FIG. 2A shows an illustrative embodiment of the fastener shown inFIG. 1;

FIG. 2B shows another illustrative embodiment of the fastener shown inFIG. 1;

FIG. 2C shows the fastener ofFIG. 2B engaged with sutures;

FIG. 2D shows the fastener ofFIG. 2B engaged with sutures that include a prepared surface to operate in conjunction with the fastener;

FIG. 3A shows the fastener ofFIG. 2A operating as a knot pushing closure device to close an opening in tissue;

FIG. 3B shows the fastener ofFIG. 2B operating to close an opening in tissue;

FIG. 4 shows an illustrative embodiment of a closure system that includes a closure device for deploying a fastener;

FIG. 5 shows a perspective view of the closure device shown inFIG. 4;

FIG. 6 shows an end view of a distal end of the closure device shown inFIG. 4; and

FIG. 7 shows an illustrative example of a method for closing an opening in tissue.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Systems, devices, and methods are disclosed herein for managing access to body lumens through tissue, including management of openings in the tissue. Embodiments disclosed herein more specifically relate to closing openings or holes in the body tissue. Several examples are described below in which a fastener may be deployed to close or substantially close (or aid in closing) a hole through which access to a body lumen is achieved. Some embodiments may be used or aid in closing and/or substantially closing openings in a blood vessel or other tissue formed during a diagnostic, therapeutic, and/or other procedure.

Closure of a hole in tissue (e.g., an arteriotomy) is often a process that is accomplished by performing a few steps. Generally, sutures are first placed around the arteriotomy. The sutures are typically placed in the vessel wall immediately surrounding or adjacent or proximate the arteriotomy. The sutures can be placed in the vessel's walls before and/or after any procedure that may be performed through the arteriotomy. After the procedure is completed or after the sutures are placed, the sutures are cinched together and locked in place to close the opening and allow healing to occur.

Embodiments of the invention include a closure system capable of closing the opening using a fastener. The fastener can be used as a knot pusher and/or as a knot replacement. Embodiments of the invention relate to a closure device that can operate as a knot pusher/suture cutter and/or a knot replacement/suture cutter. Advantageously, multiple persons (e.g., physician or nurse) can use the same device to close an opening in tissue in different ways. One person may use the closure system as a knot pusher while another person may use the closure system as a knot replacement. In both cases, the closure system may also be configured to cut or trim the sutures after deployment of the fastener to push the knot or as a knot replacement.

Embodiments of the closure system disclosed herein include a deployment or closure device and a fastener. The closure device includes an outer shaft and an actuator shaft. The actuator shaft may be configured to be displaced proximally and distally relative to the outer shaft. The actuator shaft is slidably disposed inside the outer shaft.

A fastener can be placed and held in a distal end of the outer shaft of the closure device. When the closure device is operating as a knot pusher, the sutures are threaded through the fastener or otherwise engaged with the fastener after a pushable knot has been tied in the sutures. The sutures may also be threaded through an opening in a sidewall of both the actuator shaft and the outer shaft. The outer shaft or the actuator shaft can then be used to push on the fastener, which in turn pushes the knot to cinch the sutures and lock the sutures in place.

The fastener is pushed towards the opening without displacing the actuator shaft relative to the outer shaft in one embodiment. Because the openings in the sidewalls of the outer shaft and the actuator shaft may be configured as cutters, the sutures can be cut or trimmed by moving the outer shaft relative to the actuator shaft.

The following discussion refers to a vessel and to openings that may be formed in the vessel's wall such as an arteriotomy. One of skill in the art, with the benefit of the present disclosure, can appreciate that embodiments of the invention can be used to close or substantially close gaps, discontinuities, or other openings in tissue in addition to vessels.

FIG. 1 shows an illustrative embodiment of afastener100 that is configured to close or aid in closing openings in tissue.FIG. 1 illustrates anopening110 in tissue, such as avessel112. The opening110 (e.g., an arteriotomy) may often be formed during a diagnostic, therapeutic and/or other procedure to access abody lumen114. Once the procedure is finished, theopening110 is usually at least partially closed.

In this example, sutures102 are used to close theopening110. Thesutures102 are placed in the walls of thevessel112 proximate theopening110. In this example, thesutures102 surround theopening110 and are drawn through thefastener100. In other examples, the sutures may be placed at various locations about or proximate theopening110. Thefastener100, after thesutures102 are drawn tight or cinched, can lock thesutures102 in place while holding theopening110 closed, allowing theopening110 to heal. As previously stated, locking thesutures102 in place can include pushing a knot towards the opening110 or deploying thefastener100 as a knot replacement.FIG. 1 illustrates thefastener100 as a knot replacement. No knot is formed in thesutures102 and thefastener100 operates to prevent thesutures102 from loosening. Thesutures102 may be locked in place by securing or holding thesutures102 in thefastener100 as described in more detail below. The sutures can be held by friction or by deforming the knot replacement or the like.

FIGS. 2A-2D illustrate various embodiments of a fastener.FIG. 2A shows an illustrative embodiment of afastener200.FIG. 2B shows another illustrative embodiment of afastener220.FIG. 2C illustrates the fastener ofFIG. 2B clamping sutures.FIG. 2D illustrates the fastener ofFIG. 2B using sutures that are configured to engage with thefastener220. Thefasteners200 and220 are examples of thefastener100 illustrated inFIG. 1.

Thefastener200 illustrated inFIG. 2A can be used as a knot pusher and/or as a knot replacement to close theopening110 in thevessel112. Thefastener200 includes abody210 and anopening202. Thesutures102 can be drawn through theopening202 using, for example, a snare device. Once thesutures102 are drawn through theopening202, thefastener200 can be deployed to close or to aid in closing theopening110.

Thefastener200 has abody210 with dimensions or shape including athickness204, awidth206 and aperimeter208. Thefastener200 or thebody210, by way of example and not limitation, may have a diameter of approximately 10 mm. The diameter may be smaller, for example, on the order of 5 mm or 3 mm. Smaller dimensions are also possible. A thickness of thebody210, by way of example only, may be about 5 mm or smaller such as 4 mm or 3 mm or smaller. The arrangement or configuration of the dimensions of thebody210 can vary. Theperimeter208, for example can be circular, elliptical, polygonal or other shape. The perimeter and/or other dimensions of thefastener200 may be symmetrical or asymmetrical. Thewidth204 may be greater than, equal to, or less than thewidth206. A cross section of thebody210 may be rectangular, elliptical, cone-shaped, polygonal, or the like.Interior walls212 of theopening202 may be smooth, roughened, jagged, or the like. Thewalls212 may be configured to engage and hold thesutures102 in order to lock thesutures102 in place. Thewidth204 may be configured to exert a certain force on theopening202 to securely hold thesutures102. For example, the size or dimensions of theopening202 and/or thewidth204 of thefastener200 may be selected according to the number ofsutures102 to be held and/or the corresponding dimensions of thesutures102 and/or the type ofsutures102. This ensures that, for a given situation, the appropriate fastener may be selected.

Theopening202 may have dimensions that accommodate a predetermined number of sutures. For example, when thefastener200 is used as a knot pusher, theopening202 may be sized to permit the passage of a predetermined number of sutures while preventing the passage of a knot formed in the sutures. As a result, distal movement of thefastener200 pushes or advances a pushable knot towards the opening110 when closing theopening110.

When thefastener200 functions as a knot replacement, theopening202 may be configured to frictionally (or otherwise) engage thesutures102 in a manner that prevents thefastener200 from sliding along thesutures102 or otherwise becoming displaced in the absence of sufficient force. As a result, a force can be applied to thefastener200 to cinch thesutures102 and deploy thefastener200 towards theopening110. When the deployment force is removed, theopening202 or more generally thefastener200 is sufficiently engaged with thesutures102 to prevent displacement of thefastener200 and prevent thesutures102 from loosening at least until the opening is sufficiently healed or until any other appropriate time.

In one example, thebody200 is formed of a relatively inelastic material. When thefastener200 is used to push a knot, the relative inelasticity of thefastener200 ensures that the knot is pushed towards theopening110 and does not pass through theopening202. In this example, the dimensions of the knot are larger than the dimensions of theopening202 and the knot will not pass into theopening202 during the procedure of closing theopening110 with a knot.

Thefastener200 may also hold thesutures102 by friction and operate as a knot replacement. In this example, the size of theopening202 is selected such that thesutures102 have a tight fit when drawn through theopening202. The tight fit can be overcome to deploy thefastener200, but exerts sufficient force to prevent thesutures102 from slipping or loosening.

In another example, thefastener200 can also be crimped and plastically deformed to hold thesutures102 in place. In this example, theopening202 is effectively closed on thesutures102 to clamp thesutures102 in place.

FIG. 2B illustrates another example of afastener220. Thefastener220 may have dimensions like or similar to the dimensions and shape of thefastener200. Many of the dimensions of thefastener200 may also apply to thefastener220. In this example, however, abody224 of thefastener220 is more elastic than thebody210 of thefastener200. Alternatively, aportion226 of thebody224, surrounding anopening222, may be more elastic or flexible than the rest of thebody224 such as theportion228.

In this example, theopening222 may be formed as a slit in thebody224 or in theportion226. Because the body224 (or portion thereof) is relatively more elastic compared to thefastener200, theopening222 may elastically deform sufficiently to allow thesutures102 to be drawn through theopening222. The elastic force or aspect of thebody224 applies a force on thesutures102 to lock thesutures102 in place. The sides or walls of theopening222 press against thesutures102 to hold the sutures in place, for example by friction. The friction can be overcome when deploying thefastener220 but is sufficient to keep thefastener220 in place and securely hold thesutures102 in place after deployment.

FIG. 2C illustrates an example of thefastener210 engaged with thesutures102 and holding thesutures102 in place. As shown inFIG. 2C, the sides of theopening222 press against thesutures102 to hold thesutures102 in place after thefastener210 is deployed. A larger width may increase the force with which thesutures102 are held.

FIG. 2D illustrates thefastener220 that is configured to hold orsecure sutures230. In this example, thesutures230 include a prepared surface orarea232 that is configured to engage with thefastener220. Theprepared area232 may include barbs or other feature that are oriented such that thesutures230 pass through theopening222 in one direction easier than the other direction. When closing theopening110, theprepared area232 may be oriented such that once thefastener220 can be pushed distally towards theopening110. Theprepared area232 inhibits or prevents thefastener220 from moving proximally. When properly deployed, theprepared area232 may be located in theopening222. Thus, thesutures230 are positioned prior to deployment of thefastener220. In addition to barbs, theprepared area232 may be roughened, coated with an adhesive, or otherwise prepared to engage thefastener220 to lock thesutures230 in place with theopening110 closed.

The fastener220 (or the fastener200) may hold thesutures102, or230 in place by friction, adhesive, and/or structural impediment (e.g., a roughened surface or barbed surface).

Theopening202 or222 may also be configured to extend to the perimeter of the fastener. Thus, the sutures can be loaded into the fastener through the side of the fastener rather than having to use a snare to draw the sutures through the opening. The patch formed by the opening may be a straight line, or include curves, or other path with sharper corners.

FIG. 3A illustrates the fastener operating as a knot pusher. In this example, a pushable ormovable knot302 has been formed in thesutures102.Ends304 of the sutures102 (which may be color coded to aid in closing the opening to allow the physician to know on which end to pull) are drawn through theopening202. Theopening202, which is typically sized such that theknot302 cannot enter therein, or more specifically thebody224 proximate theopening202 can then push theknot302 towards the opening110 during deployment of thefastener200. Once thefastener200 has pushed the knot such that thesutures102 are cinched tight and theopening110 remains closed, thefastener200 can be removed.

FIG. 3B illustrates the fastener operating as a know replacement. InFIG. 3B, thefastener210 is pushed distally towards the opening110 after thesutures102 are drawn through theopening222. When finally deployed and after thesutures102 are cinched, theopening222 or body of thefastener220 engages thesutures102 with sufficient force to prevent thesutures102 from loosening. As previously stated, theopening222 may have a frictional fit with thesutures102 that holds thesutures102 in place long enough for healing to occur at theopening110. Theopening222 may also have engage the sutures with an adhesive or with structure. The interior walls (e.g.,walls212 inFIG. 2A) of the opening222 (or of the opening202) may be roughened to improve the frictional force or have impeding structure that is configured to facilitate movement of the fastener in the distal direction and impede movement of the fastener in the proximate direction. Thesutures102 may have similar impeding structure as previously described.

FIG. 4 shows an illustrative embodiment of a closure system that includes aclosure device400 and thefastener100. The closure system can act or operate as either a knot pushing system or a knot replacement system. Theclosure device400 includes anouter shaft402 with aproximal end410 and adistal end408. The outer perimeter, inner perimeter, and/or cross-sectional shape of theouter shaft402 can be circular, polygonal, or other shape.

Theclosure device400 also includes anactuator shaft404 with aproximal end414 and adistal end412. The outer perimeter, inner perimeter, and/or cross-sectional shape of theactuator shaft404 can be circular, polygonal, or other shape. Theactuator shaft404 can be moved in both distal and proximal directions relative to theouter shaft402. Similarly, theouter shaft402 can be moved in both distal and proximal directions relative to theactuator shaft404. Theouter shaft402 and theactuator shaft404 can be moved at the same time or separately. Theactuator shaft404 is typically configured to slidably reside inside theouter shaft402. In one example, an outer perimeter orsurface424 of theactuator shaft404 is in contact with an inner perimeter orsurface426 of theouter shaft402. The friction between the outer surface of theactuator shaft404 and the inner surface of theouter shaft402 may be sufficient to prevent inadvertent movement but also enable a user to operate theclosure device400 and achieve relative movement between theactuator shaft404 and theouter shaft402.

During operation of the closure system, thefastener100 is placed or loaded in arecess406 formed in thedistal end408 of theouter shaft402. Therecess406 is typically sized and configured to hold thefastener100. Therecess406 may be configured such that a surface of thefastener100 extends out of the recess, is flush with the edge of the recess or is inside of the recess. Thefastener100 may engage the recess with sufficient friction to enable theclosure device400 to deploy thefastener100 while retaining thefastener100 within therecess406 until thefastener100 is positively expelled or discharged by the user. For example, distal movement of theactuator shaft404 relative to theouter shaft402 can dislodge or expel thefastener100 from therecess406.

After (or before in some embodiments) thefastener100 is loaded in therecess406, thesutures102 are drawn through the opening402 (which is an example of theopenings212 and222) of thefastener100 and through theopenings416 and418, respectively, in the sidewalls of theactuator shaft404 and theouter shaft402. Theopenings416 and418 are initially aligned such that thesutures102 can be drawn through them when preparing the closure system. When theouter shaft402 and theactuator shaft404 are non-circular or have a cross section that is not a circle, it is easier to maintain alignment of theopenings416 and418. For example, hexagonally shaped outer andactuator shafts402 and404 can provide proper alignment for theopenings416 and418 as well as ensure that the alignment is maintained during use of theclosure device400. In another example, theouter shaft402 and theactuator shaft404 may have a tongue and groove arrangement (another example of a non-circular arrangement) to keep the shafts aligned as discussed herein.

More specifically, the inner cross section of theouter shaft402 and the outer cross sectional shape of theactuator shaft404 may be the same to as to allow for relative movement in the distal and proximal directions while allowing theopenings416 and418 to be aligned using only proximal and distal movement of the outer and/or actuator shafts rather than rotational movement of theactuator shaft404 relative to theouter shaft402. In other words, theouter shaft402 and the actuator shaft are configured to allow for distal and proximal movement but not relative rotational movement in one embodiment.

FIG. 4 illustrates that theclosure device400 and thefastener100 can be used as a knot pusher. When used as a knot pusher, a sliding knot is formed in thesutures102 before thesutures102 are drawn through theopening402 and theopenings416 and418. Theouter shaft402 and thefastener100 can then be used to push the knot to theopening110. Distal movement of theouter shaft402 translates to distal movement of thefastener100, which in turn pushes the knot distally towards theopening110. Often, theactuator shaft404 is moved distally as well when the closure device is also configured to trim thesutures102 to prevent thesutures102 from being trimmed prematurely. In one example, theclosure device400 may include a lock that prevents relative movement until the lock is released by the user.

Theopening402 is sized such that the knot does not pass through theopening402. When thesutures102 are cinched tight and thesutures102 are locked such that theopening110 in the vessel or other tissue is closed or substantially closed, theactuator shaft404 can be moved proximally. When theactuator shaft404 is moved proximally relative to theouter shaft402, acutter420 formed in theactuator shaft404 may engage with acutter422 formed in theouter shaft402 to cut or trim the sutures. In other words, thesutures102 can be cut or trimmed by a scissor action between theactuator shaft404 and theouter shaft402. After the procedure or after the know is pushed, theclosure device400, including thefastener100 which is still lodged in therecess406, can be withdrawn.

In an alternative example, theclosure device400 deploy thefastener100 as a knot replacement. In this example, thesutures102 are drawn through theopening402 and through theopenings416 and418. Thesutures102 can be cinched tight to close theopening110 and theactuator shaft404 can be moved distally to dislodge thefastener100 from theouter shaft402. The distal movement of theactuator shaft404 can be performed to push thefastener100 distally while holding on to theends304 of thesutures102 and/or a proximal end of theouter shaft402. This ensures that thesutures102 remain tight until thefastener100 is properly placed adjacent the opening in the tissue.

For example, theouter shaft402 can be used to place thefastener100 against theopening100. In this case, theactuator shaft404 is held against thefastener100 while theouter shaft404 is moved proximally. The effect is that thefastener100 is dislodged from thedistal end408 of theouter shaft402. In this example, thefastener100 may frictionally or otherwise engage thesutures102 as described herein such that thesutures102 are held in place and theopening110 remains closed.

Theopening111 is sized such that the knot does not pass through theopening111. When thesutures102 are cinched tight and thesutures102 are locked such that theopening110 in the vessel or other tissue is closed or substantially closed, theactuator shaft404 can be moved proximally. When theactuator shaft404 is moved proximally relative to theouter shaft402, acutter420 formed in theactuator shaft404 may engage with acutter422 formed in theouter shaft402 to cut or trim the sutures. In other words, thesutures102 can be cut or trimmed by a scissor action between theactuator shaft404 and theouter shaft402. After the procedure or after the knot is pushed, theclosure device400, including thefastener100 which is still lodged in therecess406, can be withdrawn.

Thecutters420 and422 can be formed in sidewalls of theouter shaft402 and theactuator shaft404. Thecutters420 and422 can be arranged such that distal and/or proximal movement of the actuator shaft404 (or of the outer shaft402) trims thesutures102, for example, with a scissor effect. In one example, theopenings416 and418 may have a trapezoidal shape to aid in the scissor effect in both proximal and distal directions. For example, theactuator shaft404 and theouter shaft402 may be configured such that thesutures102 are cut in the opposite direction using theedges428 and430. When theopenings416 and418 are trapezoidal, theedges428 and430 have a scissor like arrangement with respect to lone another like thecutters420 and422. In one example, thesutures102 could be trimmed at the same time that thefastener100 is dislodged from theouter shaft402. Thus, distal movement of theactuator shaft404 can expel thefastener100 from theouter shaft402 and trim thesutures102 at substantially the same time.

FIG. 5 shows a perspective view of theclosure device400. Theclosure device400 illustrates that theactuator shaft404 and theouter shaft402 are configured to be slidably displaced relative to each other. Theactuator shaft404 may be in contact with theouter shaft402. The contact between theactuator shaft404 and theouter shaft402 aids in the scissor action that trims the sutures as previously described. Alternatively, theclosure device400 may be configured such that a space is present between theactuator shaft404 and theouter shaft402. A space may facilitate relative movement while still preventing relative rotational movement between theactuator shaft404 and theouter shaft402. The space may be small enough to not interfere with the ability of theclosure device400 to trim or cut the sutures.FIG. 5 further illustrates that the sutures exit the closure system through theopenings418. Thus, thesutures102 can be grasped by a user of the closure system as necessary to either tighten the sutures and/or deploy the fastener as a knot pusher or a knot replacement.FIG. 5 also illustrates a lock502 located, in this example at a proximate end of theclosure device400. The lock502 may be configured to engage with both theouter shaft402 and theactuator shaft404 to prevent relative movement between them.

FIG. 6 illustrates a perspective view of the distal end of theclosure device400.FIG. 6 illustrates that therecess406 may be circular in shape while theinterior surface426 may have another shape (e.g., hexagonal or other shape that prevents relative rotational movement between the outer and actuator shafts). This enables thefastener100 to be more easily loaded into therecess406 and still enable theopenings416 and418 to be easily aligned.FIG. 6 further illustrates that theactuator shaft404 is proximally withdrawn.

Therecess406 may be configured with a ridge or other retaining mechanism that operates to retain thefastener100 in therecess406. The effect of the retaining mechanism can be overcome and thefastener100 dislodged by proximal and/or distal translation of theactuator shaft404 relative to theouter shaft402. In one example, the retaining mechanism includes dimensions that are sufficiently smaller than the dimensions of thefastener100 to achieve a frictional fit. In another embodiment, thefastener100 may be configured with a complementary structure that removably engages with therecess406 to retain thefastener100 in the recess until thefastener100 is positively dislodged by a user. For example, therecess406 may include a lip structure that engages with a groove formed on in thefastener100.

FIG. 7 illustrates an example of a method for closing an opening in tissue. The method may begin inbox702 by loading a closure device with a fastener. Loading the closure device can include drawing the sutures through the fastener as well as through the openings formed in the sidewalls of the actuator and outer shafts of the closure device. Loading the closure device also include placing the fastener in the recess formed in the distal end of the closure device. When operating as a knot pusher, a knot is formed in the sutures. In addition, one of skill in the art can appreciate that the sutures are typically placed in the tissue prior to loading the closure device.

Inbox704, the fastener is deployed. Deploying the fastener can include moving the closure device in a distal direction to push the fastener (and thus the knot when operating as a knot pusher) towards the opening in the tissue. Once the fastener is adjacent the opening and the sutures are tightened, the suture can be dislodged by advancing the actuator shaft distally relative to the outer shaft. The distal end of the actuator shaft presses against the fastener and pushes the fastener out of the distal end of the outer shaft. In one example, the actuator shaft may be held stationary while the outer shaft is moved proximally.

Inbox706, the sutures are trimmed. Because the sutures are threaded through openings in the sidewalls of the closure device, which openings are configured with one or more cutters, the sutures can be trimmed by relative movement of the outer and actuator shaft. By way of example only, the sutures can be trimmed when the fastener is dislodged from the distal end of the outer shaft. Alternatively, the sutures can be trimmed by moving the actuator shaft proximally after the fastener is properly placed.

Embodiments of the closure system (e.g., the closure device, fastener, or elements thereof) included therein may be made of any suitable material, including a bioabsorbable, biodegradable, or bioerodable material. Such materials may include polycaprolactone (PCL), poly(D, L-lactic acid), Poly-L-Lactic acid, poly (lactide-co-glycolide), poly(hydroxybutyrate), polyanhydrides, poly(glycolic acid, other bioabsorbable or biodegradable materials or combos thereof. At least a portion of the closure device (e.g., that forms the cutting edges or the material defining theopenings416 and418) is formed of a material capable of trimming the sutures.

The closure system disclosed herein (can be comprised of a variety of known suitable materials, including stainless steel, silver, platinum, tantalum, palladium, nickel, titanium, nitinol, nitinol alloys having tertiary materials, niobium-tantalum alloys optionally doped with a tertiary material, cobalt-chromium alloys, or other known biocompatible materials. Such biocompatible materials can include a suitable biocompatible polymer in addition to or in place of a suitable metal. A device or member can include biodegradable, bioerodable, or bioabsorbable materials.

In one embodiment, the closure device or fastener can be made at least in part of a high strength, low modulus metal alloy comprising niobium, tantalum, and at least one element selected from the group consisting of zirconium, tungsten, and molybdenum. The materials composing the medical devices or members according to the present invention may provide superior characteristics with regard to bio-compatibility, radio-opacity and MRI compatibility.

Furthermore, the closure device body or other medical device, including the closure device, can be formed from a ceramic material. In one aspect, the ceramic can be a biocompatible ceramic that optionally can be porous. Examples of suitable ceramic materials include hydroxylapatite, mullite, crystalline oxides, non-crystalline oxides, carbides, nitrides, silicides, borides, phosphides, sulfides, tellurides, selenides, aluminum oxide, silicon oxide, titanium oxide, zirconium oxide, alumina-zirconia, silicon carbide, titanium carbide, titanium boride, aluminum nitride, silicon nitride, ferrites, iron sulfide, and the like. Optionally, the ceramic can be provided as sinterable particles that are sintered into the shape of a closure device or layer thereof.

Moreover, the closure device or fastener can include a radiopaque material to increase visibility during placement. Optionally, the radiopaque material can be a layer or coating any portion of the device or member. The radiopaque materials can be platinum, tungsten, silver, stainless steel, gold, tantalum, bismuth, barium sulfate, or a similar material.

It is further contemplated that the external surface and/or internal surface of the devices or members (e.g., exterior and luminal surfaces) as well as the entire body can be coated with another material having a composition different from the primary material. The use of a different material to coat the surfaces can be beneficial for imparting additional properties to the device or member, such as providing radiopaque characteristics, drug-reservoirs, and improved biocompatibility.

The closure device can also be formed frombiocompatible polymeric materials that can include a suitable hydrogel, hydrophilic polymer, hydrophobic polymer, biodegradable polymer, bioabsorbable polymer, and monomers thereof. Examples of such polymers can include nylons, poly(alpha-hydroxy esters), polylactic acids, polylactides, poly-L-lactide, poly-DL-lactide, poly-L-lactide-co-DL-lactide, polyglycolic acids, polyglycolide, polylactic-co-glycolic acids, polyglycolide-co-lactide, polyglycolide-co-DL-lactide, polyglycolide-co-L-lactide, polyanhydrides, polyanhydride-co-imides, polyesters, polyorthoesters, polycaprolactones, polyesters, polyanydrides, polyphosphazenes, polyester amides, polyester urethanes, polycarbonates, polytrimethylene carbonates, polyglycolide-co-trimethylene carbonates, poly(PBA-carbonates), polyfumarates, polypropylene fumarate, poly(p-dioxanone), polyhydroxyalkanoates, polyamino acids, poly-L-tyrosines, poly(beta-hydroxybutyrate), polyhydroxybutyrate-hydroxyvaleric acids, polyethylenes, polypropylenes, polyaliphatics, polyvinylalcohols, polyvinylacetates, hydrophobic/hydrophilic copolymers, alkylvinylalcohol copolymers, ethylenevinylalcohol copolymers (EVAL), propylenevinylalcohol copolymers, polyvinylpyrrolidone (PVP), combinations thereof, polymers having monomers thereof, or the like.

Accordingly, embodiments of the invention can include or be coated with a drug or beneficial agent, for example an antibiotic to improve the use of the closure device.

The invention is susceptible to various modifications and alternative means, and specific examples thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular devices or methods disclosed, but to the contrary; the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the claims.

The invention is susceptible to various modifications and alternative means, and specific examples thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular devices or methods disclosed, but to the contrary; the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the claims.

The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (20)

What is claimed is:

1. A closure device for closing an opening in tissue, the closure device comprising:

hollow actuator shaft having a distal end, a first opening, and a first cutter formed in the first opening;

an outer shaft having a second opening, and a second cutter formed in the second opening, wherein the actuator shaft is configured to move slidably within the outer shaft;

and

a recess formed in the distal end of the outer shaft and configured to removably receive a fastener having an opening, wherein the hollow actuator shaft includes a hollow interior channel that is aligned with the opening of the fastener so that a suture passing through the opening of the fastener and through the first and second openings extends through the hollow interior channel disposed between the opening in the fastener and the first and second openings of the hollow actuator shaft and the outer shaft, respectively;

wherein positioning the distal end of the actuator shaft against the proximal surface of the fastener and proximal movement of the outer shaft relative to the actuator shaft dislodges the fastener from the recess, and

wherein upon positioning the fastener within the recess formed in the distal end of the outer shaft and the distal end of the actuator shaft against the proximal surface of the fastener, the first opening partially overlaps the second opening in a longitudinal direction of the actuator shaft and the outer shaft.

2. The closure device ofclaim 1, wherein the fastener pushes a knot when sutures are passed through an opening formed in the fastener after tying a knot in the sutures, wherein the opening is sized to prevent the knot from passing through the opening.

3. The closure device ofclaim 1, wherein the fastener includes an opening formed therein, wherein the fastener replaces a knot in the sutures when the sutures are locked in the opening in the fastener.

4. The closure device ofclaim 3, wherein at least a portion of a body of the fastener proximate the opening has an elasticity configured to grip the sutures and hold the sutures in place after deployment of the fastener.

5. The closure device ofclaim 1, wherein distal or proximal movement of the actuator shaft causes the first cutter to engage with the second cutter to trim sutures that pass through the first opening and the second opening.

6. The closure device ofclaim 1, wherein the outer shaft and the actuator shaft each have a non-circular shape to prevent rotational movement of the actuator shaft relative to the outer shaft.

7. The closure device ofclaim 6, wherein the recess formed in the distal end of the outer shaft configured to removably receive a fastener is circular.

8. The closure device ofclaim 1, wherein the fastener is configured to engage the recess with a frictional fit.

9. The closure device ofclaim 1, wherein the fastener includes an opening, wherein an inner wall of the opening comprises an adhesive.

10. The closure device ofclaim 1, wherein the recess includes a lip structure that engages with a groove formed in the fastener to retain the fastener in the recess.

11. The closure device ofclaim 1, further comprising a lock at a proximal end of the closure device that engages with both the outer shaft and the actuator shaft to prevent relative axial movement therebetween.

12. A closure system for closing an opening in tissue, the closure system comprising:

a flat shaped fastener having a height that is less than its width, the fastener having an opening, wherein sutures are received through the opening; and

a closure device configured to deploy the fastener, the closure device including an outer shaft and an actuator shaft configured to selectively press against and deploy the fastener as either a knot replacement or a knot pusher, the closure device being further configured to trim the sutures after deployment of the fastener,

wherein upon positioning the fastener within the recess formed in the distal end of the outer shaft and the distal end of the actuator shaft against the proximal surface of the fastener, the first opening partially overlaps the second opening in a longitudinal direction of the actuator shaft and the outer shaft, proximal and distal ends of each of the first opening and the second opening being inclined in the same direction towards a longitudinal axis of the outer shaft and the actuator shaft.

13. The closure system ofclaim 12, wherein the actuator shaft is slidably disposed inside the outer shaft.

14. The closure system ofclaim 13, wherein the outer shaft includes a first opening having a first cutter and the actuator shaft includes a second opening having a second cutter, wherein the sutures are drawn thorough the first and second openings such that distal or proximal movement of the actuator shaft relative to the outer shaft causes the first cutter and the second cutter to cut the sutures.

15. The closure system ofclaim 14, wherein the first opening and the second opening each have a trapezoidal shape so as to cut the sutures when the actuator shaft moves distally or when the actuator shaft moves proximally.

16. The closure system ofclaim 14, wherein the actuator shaft is hollow so as to include a hollow interior channel that is aligned with the opening of the fastener so that the sutures passing through the opening of the fastener and through the first and second openings of the hollow actuator shaft and outer shaft, respectively, extend through the hollow interior channel disposed between the opening in the fastener and the first and second openings of the hollow actuator shaft and the outer shaft, respectively.

17. The closure system ofclaim 12, wherein the actuator shaft and the outer shaft are shaped to prevent rotational movement of the actuator shaft relative to the outer shaft.

18. The closure system ofclaim 13, wherein the outer shaft has an inner perimeter with a non-circular shape and an outer perimeter of the actuator shaft has a corresponding non-circular shape that allows relative movement in distal and proximal directions.

19. The closure system ofclaim 13, wherein a body of the fastener comprises one or more of:

an elastic material, wherein the body is configured to hold the sutures in place by friction; or

an inelastic material, wherein the opening is configured to receive the sutures and prevent a knot from entering the opening when acting as a knot pusher.

20. The closure system ofclaim 12, wherein the flat shaped fastener has a cross-sectional shape that is non-circular.

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